January 8, 2021
Targeted drug delivery (TDD) prescriptions are usually labeled with a Beyond-Use Date, or BUD—the date or time after which the compounded sterile preparation shall not be administered, stored or transported.
BUDs help to protect patients. TDD medications are compounded and then stored in the closed system of a vial or syringe. BUDs tell clinicians when the integrity of that closed system may begin to be at risk, whether through chemical degradation, microbial contamination or proliferation, and therefore should not be administered to patients.1
BUDs can vary significantly among preparations and pharmacies based on the formulation, current scientific literature, risk of microorganism contamination and sterilization method used. For both TDD patients and providers, longer BUDs come with some significant benefits.
For many TDD patients, traveling to a hospital or clinic for a refill can be a challenge. These patients are at higher risk of missing or needing to delay an appointment. An extended BUD can reduce the stress of missed or delayed appointments, allowing more time to reschedule without needing to reorder the prescription.
For providers, extended BUDs can help reduce the financial liability when these appointments are missed or rescheduled. Under a buy-and-bill model, providers would be unable to bill for medication that was not administered prior to its BUD. A longer BUD allows more time to use the medication, and therefore more time for the patient to travel to the office or clinic. Under other billing models, re-ordering prescriptions for missed appointments can place an unnecessary burden on staff.
Extended BUDs at room temperature are especially valuable for providers. The clinic or hospital staff does not need to worry about having enough space in the refrigerator or freezer, and providers do not need to allow time for the medication to reach the required temperature before administering it to a patient.
*All patient-specific dispenses within maximum concentrations (based on AIS Healthcare in-house data for 130,000 aseptically processed and terminally sterilized patient-specific prescriptions in 2020).
At AIS Healthcare, our investment in an advanced terminal sterilization program allows us the sterility assurance needed to offer extended BUDs. Our formulary TDD prescriptions have a BUD of 21 to 45 days (average 34 days) at room temperature,* offering patients and providers more flexibility and safety assurance.
“Our proprietary process that combines aseptic processing with terminal sterilization—and our robust, independent testing—enables us to produce patient-specific prescriptions with extended BUDs,” says Jonathan Hamer, Director of Pharmacy and Pharmacist in Charge, Dallas.
AIS Healthcare has made a multimillion-dollar, multi-year investment in our terminal sterilization equipment and processes. Our proprietary terminal sterilization program is based on extensive research and was developed in conjunction with industry experts. We have conducted and continue to conduct rigorous and independent testing and validation studies, including extractable and leachable studies, of our program. We go above and beyond to meet and exceed USP <797> requirements and produce prescriptions with extended BUDs.
“We’ve made significant investments in our pharmacies and terminal sterilization program to be able to offer all the benefits of extended BUDs to our patients and providers,” says Hamer. “It’s one of the ways that our commitment to advancing quality helps to improve lives.”